Comparison of a stent and bypass surgery for severe leg artery blockages

Paclitaxel Eluting Stent in Long Superficial Femoral Artery Obstruction: a Prospective, Randomized Comparison With Bypass Surgery Using PTFE Graft in a Finnish Multicenter Study

This study is testing whether a special stent or traditional bypass surgery works better for people with severe leg artery blockages to help them feel better in the long run.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Kuopio University Hospital (Academic / other)
• Locations: 1 site (Kuopio)
• Trial ID: NCT01450722 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the effectiveness of a paclitaxel-eluting stent versus traditional bypass surgery in patients with long obstructions in the superficial femoral artery (SFA) due to chronic lower limb ischemia. It aims to determine which treatment provides better long-term outcomes for patients suffering from severe claudication or critical ischemia. The study will enroll patients who meet specific criteria, including those with significant arterial blockages and a history of conservative treatment attempts. Participants will be randomly assigned to receive either the stent or undergo bypass surgery, with outcomes monitored over time.

Who should consider this trial

Good fit: Ideal candidates include patients with severe claudication or chronic critical ischemia and specific SFA obstructions who have not responded to conservative treatments.

Not a fit: Patients with extensive additional cardio-pulmonary or cerebro-vascular diseases that significantly increase operative risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe leg artery blockages, potentially reducing complications associated with surgery.

How similar studies have performed: Previous studies have shown varying success rates for similar endovascular treatments, but this specific comparison of stent versus bypass surgery is novel.

Eligibility criteria

Inclusion Criteria:

* Patients suffering from severe life-style limiting claudication indicating revascularization as well as patients suffering from chronic critical ischemia and having de-novo SFA obstruction with total length of 7-20 cm will be recruited.
* For claudicant patients an attempt of conservative treatment should be attempted before revacularization therapy. Both surgical bypass operation and endovascular treatment should be able to be safely performed;
* the patient has not extensive additional cardio-pulmonary and/or cerebro-vascular diseases increasing remarkably operative risk.
* At least one patent artery is to the ankle level.
* The patient has given his/her informed consent.
* Previous or simultaneus endovascular therapy of coexisting iliac disease is not a contraindication but study groups should be balanced.
* Unplanned common femoral artery endarterectomy is not a contraindication when it is done at the same intervention to facilitate anastomosis creation.

Exclusion Criteria:

* Patients who have not given their written informed consent.
* Patient has allergy for iodine contrast agent.
* Patient is undergoing hemodialysis.
* Patient has undergone previous endovascular treatment for the target lesion (restenotic lesions).
* Patient has also infrapopliteal disease indicating revascularization.
* Patient is pregnant

Where this trial is running

Kuopio

• Kuopio University Hospital — Kuopio, Finland (Recruiting)

Study contacts

• Principal investigator: Hannu I Manninen, Professor — Kuopio University Hospital
• Study coordinator: Hannu Manninen, professor

Conditions Chronic Lower Limb Ischemia; Peripheral Athero Obstructive Disease; Critical Ischemia; Claudication; Chronic lower limb ischemia; claudication; chronic critical ischemia